Flexible ACL instrumentation, kit and method

ABSTRACT

In a first embodiment, the present invention includes an instrumentation system for preparing a bone for soft tissue repair, the instrumentation system including a flexible drill pin capable of bending along a curved path; an aimer capable of engaging the flexible pin to bend the flexible pin; and a flexible reamer having a flexible portion along at least a portion of its length, the flexible portion comprising a plurality of laser cuts. In an alternate embodiment, the present invention may also include a method for preparing a bone tunnel in a femur adjacent a knee joint, the method including introducing a flexible drill pin into the knee joint; guiding the flexible drill pin towards a surface of the femur with an instrument introduced into the knee joint; drilling the flexible drill pin into the femur; removing the instrument from the knee joint; introducing a cannulated flexible reamer into the knee joint by placing the flexible pin within the cannulation of the flexible reamer; and reaming the bone tunnel in the femur along the path of the flexible pin.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional Patent Application No. 61/274,690 filed Aug. 20, 2009,Provisional Patent Application No. 61/343,482 filed Apr. 29, 2010, andProvisional Patent Application No. 61/358,502 filed Jun. 25, 2010, thedisclosures of which are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to instrumentation, kits andmethods for repairing damage to soft tissue, including soft tissue suchas tendons and ligaments, and particularly the anterior cruciateligament (ACL) in the knee joint.

ACL injuries are often caused by a sudden force applied to the knee, andare a common form of injury in athletic activities. The injury occurstypically when the knee is bent or twisted in an awkward direction.

Current surgical repairs of ACL injuries may be arthroscopic or open andcommonly include the formation of two bone tunnels, one in the tibia andone in the femur which serve as attachment points for a graft.Procedures for formation of the bone tunnels typically fall into twomain categories. The first commonly uses a “trans-tibial” procedure inwhich an offset guide is placed through a tunnel drilled in the tibia.The offset guide positions a guide pin, also positioned through thetibial tunnel, towards the femur to form the femoral tunnel. However,this procedure often does not allow the surgeon to position the guidepin at the correct anatomical site of the native ACL on the femur. As aresult, the rotational stability of the ACL replacement is reduced.

The second type of common surgical repair uses an “anterior-medialportal” procedure in which a similar offset guide is placed through askin incision and into the joint. Since the guide is not within thetibial tunnel in this approach, the guide is less stable but has thefreedom to be placed anywhere along the femoral notch. The length of thefemoral tunnel is shorter than is usually desired, and the surgeon hasto hyperflex the knee when inserting the drill pin. The hyperflexion hasvarious drawbacks: the surgeon loses the visual reference to anatomiclandmarks that are usually seen at a normal, ninety degree, flexion, andhyperflexion is difficult to do when using a leg holder, which istypically used in all repair procedures, or may be impossible due to apatient's build or anatomy. The surgeon can compromise tunnel integrityand thus fixation strength if the joint is not hyperflexed properly.However, if done properly, the native ACL attachment point may beaccessed.

During such arthroscopic surgical procedures, particularly on a joint,such as a knee, a surgeon will force a clear liquid, such as saline orRinger solution, into the joint to provide better viewing potentialthrough an arthroscopic camera. The clear liquid forces blood and otherfluids, suspended solids and debris from the joint. In order to maintainthe joint volume free of these other substances, the clear liquid mustbe maintained at an elevated pressure, otherwise viewing ability islost.

Typically in arthroscopic procedures, a surgeon will use a cannula, orthe like, which provides an entryway for surgical tools into the joint,as well as, detrimentally, an exit for the clear liquid from the joint.Furthermore cannulated guide tools may be passed into the joint via acannula or directly through surgical incisions. Such cannulated toolsalso provide a conduit for the clear liquid to exit the joint. When suchinstruments are used, the surgeon must increase the flow of clear fluidinto the joint, using a fluid pump for example, to maintain the requiredelevated pressure. And in some instances, such a large amount of clearfluid is lost through the cannula or cannulated guide tool thatmaintaining the elevated pressure is not feasible. Moreover, the clearfluid may exit onto the surgeon's hands and even the floor, leading todangerous safety conditions such as a slippery floor where the surgeonis working.

Thus, there is a need in ligament and tendon repair surgery forinstrumentation and procedures which may be used, for example, for ACLrepair surgery with the knee at various normal degrees of flexion,including ninety degree flexion and even at hyperflexion, if needed,which may be capable of aligning the drill pin to contact the femur atthe native ACL attachment site, which may be simple and replicatable,which may be used in arthroscopic procedures in which a clear liquid isused within the surgical space, and which have other benefits over theexisting instrumentation and procedures.

BRIEF SUMMARY OF THE INVENTION

The present invention may generally, in a first embodiment, includeinstrumentation for preparing the tibia and femur for ACL repair. Theinstrumentation may include any of a flexible pin, a femoral aimer, acurved guide tool and a flexible reamer. The use of these instrumentsmay create tunnels through the tibia and femur for attachment of a graft(whether natural or artificial) which may serve as a replacement ACL.The instrumentation may further include other elements such as a powerdrill (for connection with at least one of the flexible pin and flexiblereamer) and a starter awl (for forming a pilot divot at the insertionpoint on the tibia and/or femur).

In one embodiment, the present invention may include an instrumentationsystem for preparing a bone for soft tissue repair, the instrumentationsystem may include a flexible drill pin capable of bending along acurved path; an aimer capable of engaging the flexible pin to bend theflexible pin; and a flexible reamer having a flexible portion along atleast a portion of its length, the flexible portion comprising aplurality of laser cuts.

The flexible drill pin may be composed of Nitinol, and may furtherinclude a distal portion and a proximal portion, wherein the distalportion includes a trocar tip and the proximal portion includes a sutureconnection. The aimer may further at least substantially surround acircumference of the flexible drill pin. The flexible portion of theflexible reamer may further include discrete, interlocking portions, andmay also be cannulated along at least a portion of its length forplacement of the flexible reamer over the flexible pin. The flexibleportion may also be cannulated along at least a portion of its lengthfor placement over at least the bent portion of the flexible pin. Theflexible reamer may further include an asymmetric tip having at leastone flute positioned off-axis relative to a longitudinal axis of theflexible reamer.

The instrumentation system may further include additionalinstrumentation such as a starter awl, suture and other instruments usedin arthroscopic orthopedic surgery. The system may be used on a femurand an ACL, wherein the instrumentation system forms a tunnel in thefemur extending from the knee joint.

In an alternate embodiment, the present invention may be a method forpreparing a bone tunnel in a femur adjacent a knee joint, the method mayinclude introducing a flexible drill pin into the knee joint; guidingthe flexible drill pin towards a surface of the femur with an instrumentintroduced into the knee joint; drilling the flexible drill pin into thefemur; removing the instrument from the knee joint; introducing acannulated flexible reamer into the knee joint by placing the flexiblepin within the cannulation of the flexible reamer; and reaming the bonetunnel in the femur along the path of the flexible pin.

The method may further include the step of the instrument guiding theflexible pin along a curved path towards the surface of the femur. Theflexible drill pin may further be drilled through the femur and may exitout a lateral side of the femur. Additionally, the flexible drill pinmay follow a curved path from introduction in the knee joint to thesurface of the femur, and may follow a generally straight andsubstantially linear path from the surface of the femur, through thefemur, and out the lateral side of the femur. The instrument may be afemoral aimer or a curved guide tool. The flexible reamer may furtherinclude a flexible portion along at least a portion of a length of theflexible reamer, the flexible portion comprising a plurality of lasercuts. The flexible portion of the flexible reamer may further includediscrete, interlocking portions.

In this method, the flexible drill pin, instrument, and flexible reamermay also be introduced into the knee joint through an at least oneportal. Alternatively, the flexible drill pin and flexible reamer may beintroduced into the knee joint through a bone tunnel through a tibia,and the instrument may be introduced into the knee joint through aportal.

In another embodiment, the present invention may include instrumentationfor preparing bone tunnels which may include a flexible pin, a femoralaimer, and a flexible reamer. A first embodiment of a flexible reamermay include a tip having at least one flute wherein the flute ispositioned on the tip asymmetrically (i.e., off-axis relative to thelongitudinal axis of the reamer). The tip may further include additionalflutes which may be smaller in size than the first flute, thusmaintaining an asymmetrical tip.

The present invention may also include various embodiments for methodsof use of the instrumentation for bone tunnel preparation for ACLrepair. These embodiments may be used when the knee is positioned at a“normal” flexion, for example, at ninety degrees, and a knee holder (asis known in the art) may also be used, if needed. Typically, theflexible pin is passed through the tibia and then through the knee jointand into the femur. An anterior-medial portal may also be formed,through which the femoral aimer passes through the skin and into thejoint. The femoral aimer interacts with the flexible pin, as the pinpasses through the joint, and may guide the pin to the proper locationon the femur. In one example, the femoral aimer adjusts the trajectoryof the pin such that the pin follows a curved path from the tibia to thefemur.

A further embodiment of the methods of the present invention may includea method for preparing bone tunnels including the steps of placing aflexible pin through one of a portal or a bone tunnel, placing an aimerthrough the portal, contacting a distal portion of the pin with theaimer to alter the trajectory of the pin towards a desired position,pushing the pin through bone, placing a flexible reamer onto the pin andmoving the reamer along the pin to create a second tunnel.

In one embodiment, the method of ACL repair may include forming a tibialtunnel in a knee joint, forming an anterior-medial portal in the kneejoint, placing a flexible pin through the tibial tunnel and into theknee joint, placing a femoral aimer through the anterior-medial portal,contacting a distal portion of the pin with the aimer to alter thetrajectory of the pin towards a position on the femur, drilling the pinthrough the femur, placing a flexible reamer onto the pin and moving thereamer along the pin passing through the tibial tunnel and reaming afemoral tunnel along a portion of the length of the pin within thefemur, removing the reamer, connecting a suture and graft to a sutureconnector on a proximal end of the pin, pulling the pin proximally topull the graft through the tibial tunnel and into the femoral tunnel,and securing the graft.

In a further embodiment, the method of ACL repair may include forming atibial tunnel through a tibia. The tunnel may be directed in a proximaldirection through the tibial plateau and may open into the knee joint.The tunnel may be formed using a drill. The drill may then be removedfrom the tibia and a flexible pin may be passed up through the tibia.The pin should be passed through the tibia until a distal portionextends into the knee joint. An anterior-medial portal may also beformed through the skin to allow access into the knee joint. A femoralaimer may be passed through the portal and positioned within the kneejoint. As the distal portion of the pin enters the joint, the femoralaimer may interact with the pin to adjust the trajectory of the pin andguide it towards a desired location on the femur. Optionally, thedesired location on the femur may be marked using a starter awl, orother instrument, to form a pilot divot. Once the pin is placed againstthe femur, the pin may be passed through the femur until it exits thefemur, proximal to the knee joint, and through the adjacent skin. Aflexible reamer (which may, for example, be cannulated) may then bepositioned onto the pin such that the flexible reamer passes through thetibial tunnel and contacts the femur. The reamer may then be used toform a femoral tunnel to a specified depth. Leaving the pin in place,the reamer may then be removed from the femur and tibia. The pin mayhave a suture connector on its proximal portion (i.e., an eyelet or thelike), through which a suture is passed which may contain a graftthereon. The pin is then pulled proximally, from where it exited thefemur, to pull the suture and graft up through the tibial tunnel andinto the femoral tunnel. The graft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill. The drill may then be removed from thetibia and a flexible pin may be passed up through the tibia. The pinshould be passed through the tibia until a distal portion extends intothe knee joint. An anterior-medial portal may also be formed through theskin to allow access into the knee joint. A femoral aimer may be passedthrough the portal and positioned within the knee joint. As the distalportion of the pin enters the joint, the femoral aimer may interact withthe pin to adjust the trajectory of the pin and guide it towards adesired location on the femur. Optionally, the desired location on thefemur may be marked using a starter awl, or other instrument, to form apilot divot. Once the pin is placed against the femur, the pin may bepassed through the femur until it exits the femur, proximal to the kneejoint, and through the adjacent skin. The pin may have a sutureconnector on its proximal portion (i.e., an eyelet or the like), throughwhich a suture is passed. The pin is then pulled proximally, from whereit exited the femur, to pull the suture up through the tibial tunnel andinto the joint space. The suture and/or proximal portion of the pin maybe grasped by an instrument through the anterior-medial portal, and thepin may then be pulled backwards through the portal. A flexible reamer(which may, for example, be cannulated) may then be positioned onto thepin such that the flexible reamer passes through the portal and contactsthe femur. The reamer may then be used to form a femoral tunnel to aspecified depth. Leaving the pin in place, the reamer may then beremoved from the femur and the portal. A suture may be attached to theproximal portion of the pin. The pin may then be pulled, from its distalend, back up through the femoral tunnel, until the proximal end of thepin is visible within the knee joint. The pin may then be moved distallyback through the tibial tunnel utilizing the suture or the sutureconnector, such that the suture and suture connector are outside thetibia. A suture, containing a graft, may be placed on the sutureconnector. The pin is then pulled proximally, from where it exits thefemur, to pull the suture and graft up through the tibial tunnel andinto the femoral tunnel. The graft may then be secured.

In yet another embodiment, the method may include passing a flexible pinthrough the tibia. The pin may be directed in a proximal directionthrough the tibial plateau and into the knee joint. An anterior-medialportal may also be formed through the skin to allow access into the kneejoint. A femoral aimer may be passed through the portal and positionedwithin the knee joint. As the distal portion of the pin enters thejoint, the femoral aimer may interact with the pin to adjust thetrajectory of the pin and guide it towards a desired location on thefemur. Optionally, the desired location on the femur may be marked usinga starter awl, or other instrument, to form a pilot divot. Once the pinis placed against the femur, the pin may be passed through the femuruntil it exits the femur, proximal to the knee joint, and through theadjacent skin. A flexible reamer (which may, for example, be cannulated)may then be positioned onto the pin such that the flexible reamer drillsthrough the tibia and the femur in a single continuous motion to form atibial tunnel and a femoral tunnel. The reamer may form a femoral tunnelto a specified depth. Leaving the pin in place, the reamer may then beremoved from the femur and tibia. The pin may have a suture connector onits proximal portion (i.e., an eyelet or the like), through which asuture is passed which may contain a graft thereon. The pin is thenpulled proximally, from where it exited the femur, to pull the sutureand graft up through the tibial tunnel and into the femoral tunnel. Thegraft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill with a diameter which is narrower than thediameter of the final tibial tunnel, discussed below. Thenarrow-diameter drill may then be removed from the tibia and a flexiblepin may be passed up through the tibia. The pin should be passed throughthe tibia until a distal portion extends into the knee joint. Ananterior-medial portal may also be formed through the skin to allowaccess into the knee joint. A femoral aimer may be passed through theportal and positioned within the knee joint. As the distal portion ofthe pin enters the joint, the femoral aimer may interact with the pin toadjust the trajectory of the pin and guide it towards a desired locationon the femur. Optionally, the desired location on the femur may bemarked using a starter awl, or other instrument, to form a pilot divot.Once the pin is placed against the femur, the pin may be passed throughthe femur until it exits the femur, proximal to the knee joint, andthrough the adjacent skin. A flexible reamer (which may, for example, becannulated), having a larger diameter than the narrow-diameter drill,may then be positioned onto the pin such that the flexible reamerexpands the diameter of the tibial tunnel and contacts the femur. Thereamer may then be used to form a femoral tunnel to a specified depth.Leaving the pin in place, the reamer may then be removed from the femurand tibia. The pin may have a suture connector on its proximal portion(i.e., an eyelet or the like), through which a suture is passed whichmay contain a graft thereon. The pin is then pulled proximally, fromwhere it exited the femur, to pull the suture and graft up through thetibial tunnel and into the femoral tunnel. The graft may then besecured.

In yet another embodiment, the instrumentation may include a curvedguide tool which may have a hollow curved guide, a handle, and anoutrigger.

Additionally, the curved guide may have a bone engaging tip.Alternatively, the curved guide may have a flange, which may further beadapted to engage the surrounding anatomy adjacent to or on the bone.

The bone engaging tip may be any one of a single point, positionedanywhere on a distal end of the curved guide, or may include more thanone point, wherein the points are positioned anywhere on the distal endof the curved guide.

The flange may have an offset from a longitudinal axis of the curvedguide and may further have a shape adapted to engage a structure on hardor soft tissue at a surgical site. The offset may further be at anyangle, such as between about 0 degrees and 90 degrees. The flange mayfurther have a second offset, distal to the first offset. The secondoffset may be more than 0 degrees, and more specifically at least 20degrees, and even more particularly about 45 degrees.

Additionally, the outrigger may swivel relative to the handle and curvedguide. The outrigger may also include an extension having a longitudinalaxis along its length. The handle, curved guide, and outrigger may allbe positioned generally along a single plane. The curved guide mayfurther be hollow along its length to allow passage of a pin, guidewire,or the like therethrough, for placement into the bone. In yet anotherembodiment, a curved guide tool may include a curved guide having aflange on a distal end and an outrigger. The flange may further beadapted to substantially mate with a portion of the anatomy at thesurgical site. The outrigger may further be adapted to lay along outertissue, for example, skin, outside of the surgical site but along thesame plane as the curved guide. The curved guide tool may furtherinclude a handle.

The instrumentation may be used within a joint, such as a knee joint.Further, the instrumentation may be used on a femur bone to repairsurrounding soft tissue. For example, the instrumentation may be usedfor ACL repair, such as attachment of an ACL to the femur, wherein theACL is a natural ACL, ACL graft, ACL implant, tendon graft,bone-tendon-bone graft or the like.

The present invention also includes various embodiments for methods ofuse of the instrumentation for bone preparation for soft tissue repair,such as ACL repair. In one embodiment, the method may include forming ananterior-medial portal in soft tissue adjacent a knee joint; inserting acurved guide of a curved guide tool through the portal and into thejoint; directing a distal tip of the curved guide towards the surface ofa bone; engaging an outrigger with the outer surface of the skin of thebody, the outrigger having a longitudinal axis extending along itslength; and passing a pin through the curved guide and into the bone,wherein the pin passes through the bone and protrudes through the skinin a direction generally towards the axis of the outrigger.

The step of directing the distal tip of the curved guide towards thesurface of the bone may further include engaging the bone with thedistal tip of the curved guide wherein the distal tip is pointed. Thisstep may alternatively include engaging anatomy, such as soft tissue,overlying the bone, with the distal tip of the curved guide wherein thedistal tip is a flange. The flange may further be adapted to match theanatomy of the soft tissue. Either of the pointed tip or flangeconfigurations may provide a surgeon with assurance that the curvedguide is in proper placement for the ACL repair.

In yet another embodiment, the curved guide tool having the distal pointmay first be positioned at the surgical site. The distal point may thenbe used as an awl to mark the correct entry point for the pin. Then,this curved guide tool may be removed, and the curved guide tool havingthe flange may next be positioned at the surgical site. The curved guidetool having the flange may then be positioned on the anatomy and the pinpassed through the curved guide into the bone.

The instrumentation may include a cannulated guide tool which may have ahollow guide, a handle, and a plug. The cannulated guide tool mayfurther optionally include an outrigger. The cannulated guide mayfurther be hollow along its length to allow passage of a pin, guidewire,or the like therethrough, for placement into the joint or bone.

In one embodiment, the plug may be a type of one-way valve. The plug mayopen to allow the passage of a pin, or the like, into the joint, but mayclose to prohibit the flow of fluid from the joint and out thecannulated guide. In one arrangement, the plug may include a dam whichmay pivot on an axis between an open position and a closed position. Theplug may further include a manual activation which a surgeon may use tomanually move the dam from an open position to a closed position.

In a further embodiment, the present invention may include a cannulatedguide tool including a cannulated opening, a handle and a plugpositioned within the cannulated opening. The plug may further include adam and a pivot on which the dam rotates from a closed position,substantially blocking the cannulated opening, to an open position,substantially clear of the cannulated opening. The plug may furtherinclude a manual activation to manually pivot the dam between the openand closed positions. The plug may alternatively, in a differentarrangement, include a spring bias to maintain the dam in one of an openor closed position. The plug may further include the dam having atapered portion.

The present invention also includes various embodiments for methods ofuse of the instrumentation for bone preparation for soft tissue repair,such as ACL repair. In one embodiment, the method may includeestablishing a supply source of a clear fluid into a joint, such as aknee; forcing the clear fluid into the knee joint from the supplysource; forming an anterior-medial portal in soft tissue adjacent thejoint; inserting a cannulated guide of a cannulated guide tool throughthe portal and into the joint, the cannulated guide tool comprising aplug positioned in a closed position; directing a distal tip of thecurved guide towards the surface of a bone; and passing a pin throughthe curved guide and into the bone, wherein the plug is pivoted to anopen position upon entry of the pin into the cannulated guide. Themethod may further include removing the pin from the joint andcannulated guide, wherein the plug returns to the closed position.

Other variations of the instrumentation and methods disclosed hereinrelating to soft tissue repair, whether as to ACL or other soft tissues,are also within the scope of this invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B, illustrated as photographs, illustrate one embodiment of astarter awl.

FIGS. 2-4 illustrate various embodiments of distal tips of flexiblepins, including examples of various dimensions of the pins thereon.

FIGS. 5-8 (FIG. 8 illustrated as a photograph) illustrate variousembodiments of femoral aimers.

FIGS. 9 and 10 a-d (illustrated as photographs) illustrate variousembodiments of active femoral aimers.

FIGS. 11 and 12 illustrate a first embodiment of a curved guide tool ofthe present invention in various configurations.

FIGS. 13-18 illustrate various views of a second embodiment of a curvedguide tool of the present invention in various configurations.

FIGS. 19A-F illustrate various configurations of a distal tip of oneembodiment of a curved guide of the present invention.

FIG. 20 illustrates one configuration of using an embodiment of a curvedguide tool of the present invention.

FIG. 21 illustrates various configurations of a flange on a distalportion of an embodiment of a curved guide of the present invention.

FIGS. 22A-E illustrate additional configurations of a flange on a distalportion of an embodiment of a curved guide of the present invention.

FIG. 23 is a proximal view of one embodiment of a curved guide tool ofthe present invention.

FIG. 24 illustrates one embodiment of a method of using an embodiment ofa curved guide tool of the present invention on a knee joint.

FIG. 25 illustrates an embodiment of a method of using an embodiment ofa curved guide tool of the present invention on a knee joint.

FIG. 26 illustrates an embodiment of a method of using an embodiment ofa curved guide tool of the present invention on a knee joint.

FIG. 27 illustrates a further embodiment of a method of using anembodiment of a curved guide tool of the present invention on a kneejoint.

FIG. 28 illustrates one embodiment of a flange on a distal end of acurved guide adapted to substantially mimic the posterior portion of alateral condyle used during surgery on a knee joint.

FIG. 29 illustrates a further embodiment of a cannulated guide tool ofthe present invention.

FIGS. 30 and 31 illustrate a close-up of a proximal end of thecannulated guide tool of FIG. 29.

FIG. 32 illustrates an exploded view of the cannulated guide tool ofFIG. 29 in which an embodiment of a plug is separated from thecannulated guide tool.

FIG. 33 illustrates one embodiment of a plug of the present invention.

FIGS. 34A-C are cross-sectional views of one embodiment of a cannulatedguide tool illustrating one use of the plug therein.

FIGS. 35A and B (illustrated as a photograph), and 36A-C illustratevarious embodiments of a flexible reamer of the present invention.

FIGS. 37A-C, illustrated at photographs, illustrate one embodiment of amethod of tibial drilling in PCL repair surgery.

FIGS. 38A-E illustrate one embodiment of a method of ACL repair surgery.

DETAILED DESCRIPTION

While the following instrumentation and surgical methods may be used torepair any suitable type of soft tissue—such as ligaments and tendons ina knee, hip, ankle, foot, shoulder, elbow, wrist, hand, spine, or anyother area of anatomy—arthroscopic repairs of an ACL in a knee jointwill be the exemplary focus of the disclosure below. In most of thebelow embodiments, the present invention forms a tibial bone tunnel anda femoral bone tunnel, each of which engages one end of an ACLreplacement graft. The bone tunnels are intended to be positionedsubstantially at the location of the native ACL connection sites, thoughother locations may be used as desired or required based on the specificcircumstances of a particular patient.

In a first embodiment, the instrumentation system may optionally includea starter awl 5 configured to create a pilot divot on the bone whichwill designate an anatomic insertion point. The awl, as illustrated inFIGS. 1A-B, may form a divot within which a flexible pin, or otherinstrument, may be positioned. In one example, the awl 5 may be used toform a pilot divot on a femur to designate the location of where thefemur tunnel will be positioned.

The instrumentation system may also include a flexible drill pin 10,110, 210, various embodiments of which are illustrated in FIGS. 2-4. Thepin includes a distal portion 12 and a proximal portion (not shown). Thedistal portion 12 includes a trocar tip and may further include atapered surface. The proximal portion may include a suture connectionsuch as an eyelet, or the like, for connection of a suture to the pin.FIG. 3 illustrates one embodiment of a simple distal portion of a pinwhich includes a trocar tip. FIGS. 2 and 4 illustrate alternativeembodiments which include both a trocar tip and at least one taperedportion. For example, FIG. 2 includes a “neck” within the distal portion12 which provides for greater flexibility because the neck has anarrower diameter than the rest of the pin—for example, the neck mayhave a diameter of about 1.5-2.0 mm, while the trocar tip and shaft ofthe pin may have a diameter of about 2.1-2.5 mm and more specificallyabout 2.4 mm. FIG. 4 illustrates an embodiment having a single taperfrom the larger diameter of the trocar tip (for example, about 2.4 mm),to the smaller diameter of the shaft (for example, about 2.2 mm).

The flexible pin 10, 110, 210 may be flexible to allow for bending toform a curved path between, for example, a first and second bone, suchas a tibia and a femur, or through and along a curved path of acannulated instrument. The pin 10, 110, 210 should not be too stiffbecause it could have trouble obtaining the required bend to reach thedesired anatomical location. Likewise, the pin should not be tooflexible as it will have too little strength to penetrate bone and/ordense soft tissue. In one example, the pin 10, 110, 210 may be made ofNitinol which is flexible enough to maintain a bend along at least aportion of its length to the correct anatomical location. Likewise,Nitinol is strong enough to puncture bone and/or soft tissue. Moreover,Nitinol may have shape memory characteristics which allow the pin 10,110, 210 to be “set,” meaning that at a certain temperature, the pin 10,110, 210 can become more or less stiff/flexible. For example, it may bedesired that the pin be more flexible prior to an action such asdrilling (using a power drill connection) to allow for easier placementof the pin to the anatomical location. Once drilling begins, it may bedesirable for the pin to be more rigid to more easily penetrate the boneand/or soft tissue despite the bend in the pin between the two bones, aswell as to drill the bone tunnel along a generally straight andsubstantially linear path (for example, a bend may be present betweenthe bones, but within the bones the tunnels may be generally straight).Therefore, to obtain these desired results in this example, the Nitinolpin is used because Nitinol may have “shape memory” characteristics. Toutilize the shape memory characteristics, the Nitinol flexible pin isdesigned to have a “set temperature” which may be slightly higher thanbody temperature (for example, between 40 and 60 degrees Celcius). Thus,at a lower temperature, below the set temperature, the flexible pin isflexible and can be easily bent from its original, generally straightand substantially linear shape. However, at a higher temperature, abovethe set temperature, the flexible pin becomes less flexible, and furtherif, upon heating, is in a bent position, will tend to return to itsoriginal, generally straight and substantially linear shape. Thus, priorto drilling the flexible pin into the femur, the flexible pin would beat the lower temperature, and can easily bend between the tibia andfemur, or through a curved cannulated guide. But once drilling into thefemur commences, the distal portion of the flexible pin, upon enteringthe femur, will increase in temperature to above the set temperature,which causes this distal portion of the pin to tend to return to itsoriginal generally straight and substantially linear shape, whichresults in a generally straight and substantially linear femoral tunnelpath. If the flexible pin is drilled into the tibia to form a tibialtunnel path, heating would also occur thus causing the pin to form agenerally straight and substantially linear path through the tibia.

The instrumentation system may further include a femoral aimer which mayengage the flexible pin and alter the trajectory of the pin within ajoint. To continue the example of ACL repair, the femoral aimer may beused to bend the pin to have a curved path, which may be extending fromthe tibia or from a location outside of the joint, to the anatomicallocation for entry into the femur. Various embodiments of femoral aimers20, 120, 220 are illustrated in FIGS. 5-8, in which each of the aimersmay substantially surround, or alternatively, completely surround, acircumference of the flexible pin. FIG. 5 illustrates a funnel-shapedaimer 20 in which the pin is positioned within the funnel, and thefunnel is then rotated to bend the pin along a curved path to the properanatomical location on the femur. FIGS. 6 and 8 illustrate a side-slotaimer 120 which is able to be easily disengaged from the pin since itdoes not completely surround the pin when pin is placed within the sideslot. In an embodiment where the instrumentation comes as a kit, the kitmay include both left and right side-slotted aimers 120 for addeddiversity of use. A further embodiment of a femoral aimer 220, asillustrated in FIG. 7, may include a forked tip within which the pin maybe positioned.

In yet another embodiment of a femoral aimer, FIGS. 9, 10A-D illustrate“active” aimers 320, 420. Active aimers 320, 420 may include a moveabletip portion that can attach and detach itself from the pin using anytype of mechanical movement. Active aimers 320, 420 may, in someembodiments, be able to completely surround the pin during attachment,which may provide additional control of the pin during alteration oftrajectory, while also being able to detach itself from the pin withoutregard to the actual position of the pin or the pin end portions. FIG.9, for example, discloses a jaw type aimer which can open and close andwhich may completely surround the pin during use. FIGS. 10A-D disclose afurther embodiment wherein the end portion of the aimer may have adisposable tip (for example, made of PEEK), which may be replaceable (sothat the remainder of the aimer, which may be made of metal, may bereused). The disposable tip may be retractable/extendable from the endportion of the aimer.

In another embodiment, an instrumentation system of the presentinvention may include a guide pin, such as the variations discussedabove, and a curved guide tool 510, as illustrated in FIGS. 11 and 12.Curved guide tool 510 may include a handle 515, curved guide 520 and anoutrigger 550. The curved guide tool 510 is operated by a surgeongrasping handle 515 (see FIG. 20). The curved guide 520 is positionedwithin a throughbore 531 in handle 515, such that a portion 528 of theguide 520 is proximal to the handle 515 and a portion 521 of the guide520 is distal to the handle 515. A setscrew 526 secures guide 520relative to handle 515. Alternatively, setscrew 526 may instead be amovable screw such that the screw may be loosened and the guide 520 canmove in a distal-proximal direction relative to handle 515 or rotate onan axis of a linear portion (generally, 521, 528) of guide 520 relativeto handle 515. The guide 520 includes a curved distal end 522 and mayinclude a pointed distal tip 523. Distal tip 523 may be any arrangementof at least one point which is adapted to engage bone by, for example,digging into bone surface. FIGS. 19A-F illustrate various configurationsof distal tip 523. The guide 520 is hollow, and preferably cannulatedalong its entire length, to provide for the passage of, for example, aflexible drill pin or guide wire, therethrough.

The outrigger 550 includes a swivel connection 554, which may connectoutrigger main body 551 to handle 515. The main body 551 may include anopening 552. Outrigger 550 also includes an extension 553, having alongitudinal axis along its length. As seen from FIG. 11 to FIG. 12,with curved guide secured to handle 515 through setscrew 526, outrigger550 may swivel at connection 554 at least from the body of the handle515 around to the body of the curved guide 520, where guide 520 may nestwithin opening 552 at a maximum range of outrigger 550 motion towardsguide 520. Outrigger 550, throughout its swivel range, remains along thegeneral plane of the guide tool 510, wherein the plane is definedgenerally along the longitudinal axes of all of handle 515, guide 520,and outrigger 550. Opening 552 in main body 551 also allows outrigger550 to pass over the portion 528 of curved guide 520. In the embodimentof curved guide 520 connected to handle 515 through a movable screw,curved guide 520 should be positioned sufficiently in the distaldirection, relative to handle 515, to shorten the length of portion 528to allow passage through opening 552. The movable screw may be loosenedto adjust the distal-proximal arrangement of curved guide 520 relativeto handle 515. Once outrigger 550 moves over portion 528, surgeon maythen readjust the distal-proximal arrangement of curved guide 520relative to handle 515 as needed.

FIGS. 13-18 illustrate a further embodiment of the curved guide tool ofthe present invention. In this embodiment, curved guide tool 610includes a handle 615, curved guide 620 and an outrigger 650. The curvedguide tool 610 is operated by a surgeon grasping handle 615. The curvedguide 620 is positioned within a throughbore 631 in handle 615, suchthat a portion 628 of the guide 620 is proximal to the handle 615 and aportion 621 of the guide 620 is distal to the handle 615. A setscrew 626secures guide 620 relative to handle 615. Alternatively, setscrew 626may instead be a movable screw such that the screw may be loosened andguide 620 can move in the distal-proximal direction relative to handle615 or rotate on an axis of a linear portion (generally, 621, 628) ofguide 620 relative to handle 615.

The guide 620 includes a curved distal end 622 and may include a flange629. Flange 629 is either integrally formed with the distal end 622 oris connected to the distal end 622 at connection site 625. The flangemay have an offset from a longitudinal axis of the curved guide. Theoffset may further be at any angle, such as between about 0 and about 90degrees, and more particularly at about 90 degrees. The flange mayfurther include a second offset, positioned distal to the first offset.This offset, may be 0 degrees, more than 0 degrees, at least 20 degrees,at least 45 degrees, and most particularly about 45 degrees. The secondoffset may be in a different plane than the first offset, for example itmay be in a plane that is orthogonal to that of the first offset.Additional examples of flanges within the scope of this invention areillustrated in FIGS. 21, 22A-E and 23. Flange 629 may also have asurface 624 which is generally adapted to index from soft or hard tissuewithin or near the joint, perhaps by engaging the tissue and perhapseven mating with a surface of the tissue. For example, the surface 624may engage a portion of a lateral condyle on a femur in a knee joint(see FIG. 28). In one embodiment, the surface 624 may have a shape thatmatches in some manner with the shape of the tissue, for example, theshape of a condyle. Thus, as in the various FIGS. (13-18, 21-23, and28), flange may have a complex geometric shape, to match thecorresponding anatomy of the condyle. It is also envisioned that othershaped flanges may be used depending on the certain anatomy involved ina surgical procedure at a specific location in the patient.

The guide 620 is hollow, and preferably cannulated along its entirelength, to provide for the passage of, for example, a flexible drill pinor guide wire, therethrough. The outrigger 650 may include a swivelconnection 654, connecting outrigger main body 651 to handle 615. Themain body 651 may include an opening 652. Outrigger 650 also includes anextension 653, having a longitudinal axis along its length. As seen fromFIGS. 13, 15, and 16, with curved guide 620 secured to handle 615through setscrew 626, for example, outrigger 650 may swivel atconnection 654 at least from the body of the handle 615 around to thebody of the curved guide 620, where guide 620 may nest within opening652 at a maximum range of outrigger 650 motion towards guide 620.Outrigger 650, throughout its swivel range, remains along the generalplane of the guide tool 610, wherein the plane is defined generallyalong the longitudinal axes of all of handle 615, guide 620, andoutrigger 650. Opening 652 in main body 651 also allows outrigger 650 topass over the portion 628 of curved guide 620. In the embodiment ofcurved guide 620 connected to handle 615 through a movable screw, curvedguide 620 is positioned sufficiently in the distal direction, relativeto handle 615, to shorten the length of portion 628 to allow passagethrough opening 652. The movable screw may be loosened to adjust thedistal-proximal arrangement of curved guide 620 relative to handle 615.Once outrigger 650 moves over portion 628, surgeon may then readjust thedistal-proximal arrangement of curved guide 620 relative to handle 615as needed.

In yet a further embodiment, curved guide tool 810 may include, asillustrated in FIGS. 29-34, a handle 815, cannulated guide 820 and aplug 812. The cannulated guide tool 810 may further include an outrigger850. The cannulated guide tool 810 is operated by a surgeon graspinghandle 815. The guide 820 may be hollow, having a cannulated openingpreferably along its entire length, and further through the handle 815,and to a cannula entry 825, to provide for the passage of, for example,a flexible drill pin or guide wire, therethrough.

The plug 812 may be positioned within the cannulated opening ofcannulated guide 820, the cannulated opening may pass completely throughthe entire length of the tool 810, from a distal end 828 of cannulatedguide 820 to a cannula entry 825 at a proximal end of tool 810. Asillustrated in FIG. 31, plug 812 may be positioned towards the proximalend of tool 810, and generally within handle 815, though other positionsalong the cannulated opening are envisioned.

As illustrated in FIGS. 32 and 33, plug 812 may include a dam 814 and apivot 811. Plug 812 is positioned relative to the cannulated openingsuch that dam 814 may, at a closed position, be positioned tosubstantially block the path of the cannulated opening (see FIG. 31).Dam 814 may be pivoted away from the path of the cannulated opening byrotation at pivot 811, along axis A, to an open position where thecannulated opening path is substantially clear relative to dam 814. Plug812 may include various arrangements for controlling the position of dam814. As illustrated in FIGS. 31-33, plug 812 may include a manualactivation 813, controllable by, for example, a thumb of the surgeon. Asthe plug 812 is pivoted, the manual activation 813 may travel through amanual activation groove 826 in the handle 815. Groove 826 is of asufficient size to allow the manual activation 813 a full range ofmotion sufficient to pivot dam 814 from the closed position to the openposition.

FIGS. 34A-C further illustrate this embodiment of plug 812. FIG. 34Aillustrates the dam 814 at the open position, such that the path of thecannulated opening is substantially clear. FIG. 34B illustrates therotation of dam 814 around pivot 811 as dam 814 rotates from the openposition to the closed position. FIG. 34C illustrates dam 814 at theclosed position, wherein the dam substantially blocks the path of thecannulated opening.

It is envisioned that other types of valves or dams may also be used forplug 812, such as a knife valve, which, rather than pivoting on an axis,moves along a plane, in an up and down motion, perpendicular to the pathof the cannulated opening. The surgeon may be able to manually controlthe up and down motion of the dam. Alternatively, the valve could be abutterfly valve, wherein the dam would be split into two portions, andeach portion is hinged along a central, stationary, support. Each damportion can be manually actuated or be spring loaded. Other forms ofvalves, dams or the like are also envisioned.

In another embodiment to the plug 812 illustrated in the Figures, ratherthan the manual activation, the dam 814 may be spring loaded, or thelike, such that it may be biased towards either the closed position orthe open position.

Specifically, plug 812 is intended to maintain adequate clear liquidpressure inside the joint, during arthroscopic surgery, to maintainvisibility for the surgeon by forcing blood and other debris from thejoint. Clear liquids used by surgeons in arthroscopic surgery includesaline, Ringers solution, and the like.

In use, plug 812 is intended to limit the amount of clear fluid, theflow of which is designated at “L” in FIGS. 34A-C, which exits the jointthrough the cannulated guide tool 810 through the cannulated opening andout the cannula entry 825 while still permitting the surgeon to utilizethe tool 810 to, for example, pass a surgical instrument, or the like,through the cannula entry 825 and into the cannulated opening and intothe joint. Thus, plug 812 is intended to be in the closed position whenthe surgeon has positioned the tool 810 in or adjacent the joint, but isnot prepared to utilize the tool 810 or the cannulated opening. When theplug 812 is in the closed position (FIG. 34C), the dam 814 substantiallyprevents the flow of clear liquid from the cannula entry 825. Then, whenthe surgeon is prepared to use tool 810, for example, in passing a pinthrough the cannulated opening, the dam 814 may be opened to allow thepassage of the surgical instrument. Of course, it is expected that somefluid loss may occur when using the tool 810 and when the dam 814 is inthe open position.

The dam 814 may be opened or closed by the surgeon using the manualactivation 813. Additionally, the dam 814 may pivot semi-automatically.For example, as in FIG. 34B, if dam 814 were positioned somewhere inbetween the open and closed position, the force of the clear liquid flowL passing up through the cannulated opening may contact a distal face ofthe dam 814, whereby the dam 814 is forced to the closed position, whichin turn prevents further flow of liquid out of the joint and to cannulaentry 825. Moreover, the distal face of dam 814 may include a taper 816,which may provide increased pressure on the distal face of the dam 814by the clear liquid. Taper 816 may also be useful in assisting the dam814 to pivot to the closed position when dam 814 is closer to the openposition, and possibly even when the dam 814 is substantially in theopen position. This may particularly be important in the event thesurgeon is not using tool 810, but neglected to pivot dam 814 to theclosed position manually. Of course, plug 812 may also include a springbias (not shown) towards, for example, the closed position, to preventsuch an oversight by the surgeon and ensure adequate clear liquidpressure is maintained inside the joint.

When the surgeon is ready to use the tool 810, the dam 814 may be openedmanually, using manual activation 813 or by physically pressing theinstrument against a proximal face of the dam 814, forcing dam 814 intothe open position. Pressing the instrument against the proximal face ofdam 814 may also be used when a spring bias is holding the dam 814 inthe closed position, though of course, the manual activation 813 maystill be present and used in conjunction with the spring bias.

Plug 812 also allows the surgeon to do multiple tasks at once, as theuse of plug 812 frees up a hand of the surgeon, or assistant, whoordinarily may have to, for example, place a thumb at the cannula entry825 to prevent loss of clear liquid from the joint when the surgeon isnot using tool 810. Plug 812 also allows the surgeon to use one hand tocontrol the tool 810 in that the surgeon may grip the handle and use athumb to open or close plug 812 as desired.

Any of the above exemplary instrumentation systems may further include aflexible reamer 30, 130. As illustrated in FIGS. 35A-B and 36A-C,flexible reamer 30, 130 includes a shaft 37, 137 which may include aflexible portion. The flexible portion is made by taking metal tubingand forming a laser cut in the metal to a sufficient depth to allowflexing about the cut. The laser cut may extend circumferentially aroundthe outer surface of the tubing and may have a wave or sinusoidal shapeto enhance flexibility. The flexible portion is then laser welded to atip 35, 135. In a further embodiment, the laser cuts may pass completelythrough the tubing to form discrete, interlocking portions of tubingwhich may be interlocked by the shape of the cuts, for example, likejig-saw puzzle pieces, such that shaft 37, 137 may be a single piece,and the laser cut may then be applied to the tubing to form the flexibleportion. Each jig-saw puzzle piece may be a fraction offset from thepieces above and below to improve stability and may also provide asmooth function of the reamer. At the distal end of the flexible shaft37, 137 is the tip 35, 135 which may be laser welded. The tip 35, 135may have a diameter for producing a pilot hole on the surface of thebone, and may further create the tibial and/or femoral tunnel (asdiscussed below, in some methods, the tibial tunnel may be formed usinga typical stiff-shafted reamer). The entire reamer 30, 130 may becannulated such that reamer may be positioned over the pin, such thatthe pin is within the cannulated portion, which may allow the reamer totravel along the pin and form the tibial and/or femoral tunnels. Thecannulation along the flexible portion of the flexible reamer is suchthat the reamer may travel along the bent portion of the flexible pinsuch that the reamer may follow the curved path of the flexible pin. Aproximal end of flexible reamer 30, 130 includes a drive element (notshown) which may be inserted into a standard power drill chuck. Theproximal end of reamer 30, 130 may also include a stop feature to limitthe depth of a pilot hole drilled in bone. The shaft of the reamer ofthis invention is also disclosed in co-pending patent applications, U.S.application Ser. No. 12/460,310, filed Jul. 16, 2009, by the sameassignee as this patent application, entitled “Suture AnchorImplantation Instrumentation System,” and U.S. application Ser. No.12/821,504, filed Jun. 23, 2010, by the same assignee as this patentapplication, which is a continuation-in-part of U.S. application Ser.No. 12/460,310, the disclosures of which are hereby incorporated byreference herein as if fully set forth herein.

The tip 35, 135 of reamer 30, 130 may include at least one flute 136,such that the tip is asymmetric, for example, such that the flute 136 isoff-axis relative to the longitudinal axis of the reamer (positionedtowards one side of the tip). The single flute 136 may provide foreasier entry and exit from a tunnel when going over a curved pin, andmay further, for example, be positioned on the femur away from cartilageor other soft tissue located on the condyles or surrounding femoralsurface. Furthermore, the tip may include additional smaller flutes 138.In one example, two additional flutes 138 are positioned on the tip. Thetip remains asymmetrical, but the two additional flutes have numerousbenefits including better continuity of the surface of the bone tunnel(less chance that a “thread pattern” results from asymmetrical drillingusing a single flute), less wear on flute 136 and reduced breakage ofthe tip. In some embodiments, the diameter of the reamer is sufficientlylarger than the outer diameter of the pin such that the reamer may havesufficient strength of material surrounding the cannulation (throughwhich the pin is positioned).

The instrumentation system may include further instruments which may beused in soft tissue repair, such as, for example, straight stiff-shaftedreamers, various types of suture, suture graspers, pin graspers, and thelike.

The present invention also includes various surgical methods using theabove-discussed instrumentation system for repair of soft tissue. Asabove, the exemplary surgical site will be for the preparation of bonetunnels for the repair and/or replacement of a damaged ACL. For allembodiments, a flexible pin constructed of Nitinol, or the like, may beused as such material may bend prior to passing into the femur and maystill form a generally straight and substantially linear tunnel paththrough the femur.

In a first embodiment, the method of ACL repair may include forming atibial tunnel through the tibia. The tibial tunnel may have any depthsuitable to the surgery, soft tissue graft size, or the like. In oneexample, the diameter of the tunnel may be about 8-10 mm, though othersizes may be suitable as well. The tunnel may be directed in a proximaldirection through the tibial plateau and may open into the knee joint.The tunnel may be formed using a drill (stiff or flexible shaft), reameror the flexible reamer. The drill may then be removed from the tibia anda flexible pin may be passed up through the tibia. The pin should bepassed through the tibia until a distal portion extends into the kneejoint. An anterior-medial portal may also be formed through the skin toallow access into the knee joint. Typically, the anterior-medial portalwill pass directly through the skin and into the joint, without passingthrough bone. A femoral aimer may be passed through the portal andpositioned within the knee joint. As the distal portion of the pinenters the joint (such that, for example, about 10-20 mm of the distalportion of the pin is exposed within the joint), the femoral aimer mayinteract with the pin to engage the distal portion of the pin and adjustthe trajectory of the pin to bend and guide it towards a desiredlocation on the femur.

Optionally, the desired location on the femur may be marked using astarter awl, or other instrument, to form a pilot divot. Various methodsof using the starter awl may be used. One example would be to use thefemoral aimer to determine the proper location for the femoral tunnel toensure the tunnel will have a sufficient “back wall” (i.e., theposterior side of the femur) Then, a standard drill (i.e., 2.4 mm)penetrates the femur at the desired location to a depth of a fewmillimeters. The drill is then removed and the awl is used to widen thetap to about 4 mm. A second exemplary use of the awl would be to use theawl freehand and judge, using visual cues and experience, the back walldistance and proper location of the femoral tunnel. A third exemplaryuse of the awl would be to use a microfracture pick, or the like,freehand and judge, using visual cues and experience, the back walldistance and proper location of the femoral tunnel. Then, themicrofracture pick should be removed and the awl is used to widen thetap to about 4 mm.

Once the pin is placed against the femur (whether or not the awl wasused to create a pilot divot), the pin may be passed through the femuruntil it exits the femur, proximal to the knee joint, and through theadjacent skin. For example, the pin may be attached to an electric drilland drilled into the femur to a depth of about 20 mm, at which time theaimer may be released from the pin, if possible. The pin is then drilledcompletely through the femur and out through the skin.

A flexible reamer (which may, for example, be cannulated) may then bepositioned onto the pin such that the flexible reamer passes through thetibial tunnel and contacts the femur. The reamer may then be used toform a femoral tunnel to a specified depth, for example, about 30 mm,though as with all dimensions disclosed as to these methods, the depthmay be dependent on the specific surgery and may thus be greater or lessthan 30 mm or may be sufficient for penetrating through the entire femuralong the path of the pin. Leaving the pin in place, the reamer may thenbe removed from the femur and tibia. The pin may have a suture connectoron its proximal portion (i.e., an eyelet or the like), through which asuture may be passed which may contain a soft tissue graft thereon. Thepin is then pulled proximally, from where it exited the femur, to pullthe suture and graft up through the tibial tunnel and into the femoraltunnel. The graft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia, in any way known in the art. In one example, thediameter of the tunnel may be about 8-10 mm, though other sizes may besuitable as well. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill. In alternate embodiments, the femoraltunnel (discussed below) may be reamed first, followed by the tibialtunnel.

The drill may then be removed from the tibia and a flexible pin may bepassed up through the tibia. The pin should be passed through the tibiauntil a distal portion extends into the knee joint. An anterior-medialportal may also be formed through the skin to allow access into the kneejoint. A femoral aimer may be passed through the portal and positionedwithin the knee joint. As the distal portion of the pin enters thejoint, the femoral aimer may interact with the pin to adjust thetrajectory of the pin and guide it towards a desired location on thefemur. Optionally, the desired location on the femur may be marked usinga starter awl, or other instrument, to form a pilot divot. Once the pinis placed against the femur, the pin may be passed through the femuruntil it exits out the femur, proximal to the knee joint, and throughthe adjacent skin. As above, the pin may be drilled into the femur, andthe aimer, if possible, releases the pin once it is about 20 mm into thefemur. The pin may have a suture connector on its proximal portion(i.e., an eyelet or the like), through which a suture is passed. The pinis then pulled proximally, from where it exited the femur, to pull thesuture up through the tibial tunnel and into the joint space.

The suture and/or proximal portion of the pin may then be grasped by aninstrument through the anterior-medial portal, and the pin may then bepulled backwards through the portal. A flexible reamer (which may, forexample, be cannulated) may then be positioned onto the pin such thatthe flexible reamer passes through the portal and contacts the femur.The reamer may then be used to form a femoral tunnel to a specifieddepth (as above, about 30 mm, depending on the specifics of the surgicalsite). Leaving the pin in place, the reamer may then be removed from thefemur and the portal. The pin may then be loaded with a free suture(through the suture connector) and pulled, from its distal end, back upthrough the femoral tunnel, until the proximal end, and attached suture,of the pin is visible within the knee joint. The attached suture may begrasped by an instrument, through the tibial tunnel, and the pin maythen be moved distally back through the tibial tunnel, such that thesuture and suture connector are outside the tibia on the distal end ofthe tibial tunnel. A suture, containing a graft, may be placed on thesuture connector. The pin is then pulled proximally, from where the pinexited the femur, to pull the suture and graft up through the tibialtunnel and into the femoral tunnel. The soft tissue graft may then besecured by any means known in the art.

Alternatively, when reaming the femur through the anterior-medialportal, rather than first passing the flexible pin through the tibia,the pin may be immediately passed through the portal and positioned ontothe femur, and stabilized, using the femoral aimer. The pin may then bedrilled into the femur, as discussed above, followed by the use of thereamer to form the femoral tunnel, as above. The tibial tunnel maysubsequently be prepared, and the graft may then be brought into placeas above.

In yet another embodiment, the method may include passing a flexible pinthrough the tibia. The pin may be directed in a proximal directionthrough the tibial plateau and into the knee joint. Alternatively, theinitial insertion of the pin may be done by drilling a rigid pin throughthe tibia and into the joint which may then be removed and replaced witha flexible pin. However, using the flexible pin even for the initialpreparation of the tibial tunnel offers possible advantages in reducingthe time required to drill the two tunnels. An anterior-medial portalmay also be formed through the skin to allow access into the knee joint.A femoral aimer may be passed through the portal and positioned withinthe knee joint. As the distal portion of the pin enters the joint (about15 to about 20 mm), the femoral aimer may interact with the pin toadjust the trajectory of the pin and guide it towards a desired locationon the femur. Optionally, the desired location on the femur may bemarked using a starter awl, or other instrument, to form a pilot divot.Once the pin is placed against the femur, the pin may be passed throughthe femur until it exits the femur, proximal to the knee joint, andthrough the adjacent skin. As in the above embodiments, the pin may bedrilled into the femur, and once about 20 mm of the pin is within thefemur, the aimer may release the pin, if possible.

A flexible reamer (which may, for example, be cannulated) may then bepositioned onto the pin such that the flexible reamer follows the pathof the pin and drills through the tibia and the femur in a singlecontinuous motion to form a tibial tunnel and a femoral tunnel. Thereamer diameter may be, for example, about 8-10 mm. The reamer may forma femoral tunnel to a specified depth. Leaving the pin in place, thereamer may then be removed from the femur and tibia. The pin may have asuture connector on its proximal portion (i.e., an eyelet or the like),through which a suture is passed which may contain a graft thereon. Thepin is then pulled proximally, from where it exited the femur, to pullthe suture and graft up through the tibial tunnel and into the femoraltunnel. The graft may then be secured.

In another embodiment, the method may include forming a tibial tunnelthrough the tibia. The tunnel may be directed in a proximal directionthrough the tibial plateau and may open into the knee joint. The tunnelmay be formed using a drill with a diameter (i.e., about 5 mm) which isnarrower than the diameter of the final tibial tunnel (i.e., about 8-10mm), discussed below. The narrow-diameter drill may then be removed fromthe tibia and a flexible pin may be passed up through the tibia. The pinshould be passed through the tibia until a distal portion extends intothe knee joint. An anterior-medial portal may also be formed through theskin to allow access into the knee joint. A femoral aimer may be passedthrough the portal and positioned within the knee joint. As the distalportion of the pin enters the joint, to a depth of for example, about10-20 mm, the femoral aimer may interact with the pin to adjust thetrajectory of the pin and guide it towards a desired location on thefemur. Of course, movement of the pin in the proximal/distal directionmay be required, in coordination with the movement of the aimer, toproperly align the pin with the femur. Optionally, the desired locationon the femur may be marked using a starter awl, or other instrument, toform a pilot divot. Once the pin is placed against the femur, the pinmay be passed through the femur until it exits the femur, proximal tothe knee joint, and through the adjacent skin. As discussed in otherembodiments of the method, the pin may be drilled to a depth of about 20mm into the femur, at which point the aimer may release the pin. The pinis then drilled completely through the femur and skin.

A flexible reamer (which may, for example, be cannulated), having thelarger diameter than the narrow-diameter drill, may then be positionedonto the pin such that the flexible reamer expands the diameter of thetibial tunnel and contacts the femur. This embodiment may allow theflexible pin to be more easily maneuvered through the initial smalltibial drill hole compared to when the flexible pin was drilled directlythrough the tibia in an above embodiment. Moreover, the flexible reamermay have an easier time transitioning from the tibial tunnel to thefemoral tunnel when compared to an embodiment where the tibial tunnel isdrilled to its final diameter in a single pass. The reamer may then beused to form a femoral tunnel to a specified depth (i.e., about 30 mm).Leaving the pin in place, the reamer may then be removed from the femurand tibia. The pin may have a suture connector on its proximal portion(i.e., an eyelet or the like), through which a suture is passed whichmay contain a graft thereon. The pin is then pulled proximally, fromwhere it exited the femur, to pull the suture and graft up through thetibial tunnel and into the femoral tunnel. The graft may then besecured.

In another embodiment, the instrumentation system may be used in amethod of “all-inside” ACL repair. In this method, both the tibial andfemoral tunnels are prepared from portals. For example, the femoraltunnel may be prepared using the method above where the tunnel is reameddirectly through the anterior-medial portal. The tibial tunnel islikewise prepared through such a portal. First, a flexible pin isinserted through a superior portal and an aimer is inserted through ananterior portal (either medial or lateral). The pin may be directed tothe tibial insertion site, and the aimer may bend the pin at theinsertion site such that the pin is positioned towards the anteriorsurface of the tibia. The pin is then passed through the tibia (using adrill or the like), exiting out the anterior of the tibia. A flexiblereamer (having a diameter of for example 8-10 mm) is then positioned onthe pin and passes through the tibia to an appropriate depth from theinterior of the joint (i.e., starting at the tibial plateau) andextending distally into the tibia. The pin, which may include a sutureconnector, is then used to guide a graft into the femoral and tibialtunnels, through the portal, and the graft is secured.

The present invention may also be used in soft tissue repair of othersoft tissues in the body. For example, as illustrated in FIGS. 37A-C,the instrumentation system may be used to repair the Posterior CruciateLigament (PCL). In this method, a posterior (medial or lateral) portalmay be created through the skin and into the knee joint, through which aflexible pin may be passed. An aimer may be directed through an anterior(medial or lateral) portal and into the knee joint as well. The aimerinteracts with the pin and adjusts the trajectory of the pin from itsposition exiting the femur to contacting the posterior portion of thetibia, and towards the direction of the anterior portion of the tibia.The pin may then be passed through the tibia, by use of a drill forexample, from the entry position on the posterior of the tibia to anexit location on the anterior portion of the tibia. A flexible reamermay then be placed over the pin to form the tunnels having a diameterof, for example, about 8-10 mm, until it passes completely through thetibia. Finally, using techniques known in the art, a graft may be placedwithin the tunnels and secured.

FIGS. 38A-E illustrate yet another embodiment of a method of using theinstrumentation system. The main difference as compared to the abovemethods is illustrated in FIGS. 38B-E in which the flexible reamerpasses along a heavy suture through the tibial tunnel and engages theflexible pin once within the joint.

Alternative methods of preparation of the femoral tunnel may alsoinclude the curved guide tool 510, 610, 810. The curved guide tool maybe used, for example, in place of the femoral aimer to bend the flexibledrill pin towards the proper location on the femur.

The curved guide tool 510, 610 may be used, in one embodiment, in amethod of ACL repair. Specifically, the tool 510, 610 may be used toprepare the femur for reattachment of the torn ACL, attachment of areplacement graft ACL, or any similar procedure. In an exemplaryembodiment, the preparation of the femur may include creating agenerally straight and substantially linear tunnel in the femur at thedesired site on the femur for subsequent attachment of the ACL graftwithin the tunnel.

In one embodiment of ACL repair using tool 510 (tool 610 may likewise beused, though for simplicity of illustration, tool 510 will be theexemplary instrument of this embodiment), an anterior-medial portal (notshown) is created in the tissue surrounding the knee joint, as is knownin the art. A surgeon, as illustrated in FIGS. 24-26, for example, usingthe tool 510, holding the handle 515, may position the distal end 522 ofthe hollow curved guide 520 through the anterior-medial portal, and thedistal tip 523 of the curved guide may be positioned on the femursurface. The distal tip 523 is pointed and may engage the femur tosecure the distal end 522 at the desired position on the femur, in thiscase, the point of attachment of the ACL graft. Alternatively, distaltip 523 may be used as a starter awl to mark the desired attachmentpoint. Once the desired attachment point is determined and the distalend 522 is secured to the femur, the outrigger 550 is swiveled away fromthe handle 515 and rotated towards the portion 521 of curved guide 520and towards the outer skin surface of the patient (not shown). Theoutrigger 550 is swiveled until the extension 553 comes to rest on theouter skin surface of the patient, or into the surgical wound bed if theknee has been opened in that area or opened due to injury, for example.The ability of the outrigger to accurately designate the path ofmovement of the drill pin through the bone, while typically remaining onthe outer surface of the skin, allows for a less invasive surgicalprocedure. This resting position may be at any point up to and includingwhere the portion 521 of curved guide 520 is positioned within opening552 of outrigger 550. It should also be understood that opening 552prevents the outrigger main body 551 from contacting the portion 528 ofcurved guide 520.

Outrigger main body 551 may include a bend 555. Bend 555 may be appliedto main body 551 for various reasons such as to provide a corner inwhich the surgeon may position a finger to easily swivel outrigger, orto allow outrigger 550 additional swivel movement towards curved guide520 such that an angle between an axis of the curved guide, along itslength, and an axis of the outrigger, along its length, is less than ifthe bend 555, and opening 552, were not present.

With outrigger 550 and distal tip 523 in place, a pin, or the like, maybe passed up through the hollow curved guide 520 and passed into thefemur using any known means, such as a power drill, mallet, or the like.The longitudinal axis of outrigger 553 may be generally within a planeof the handle 515 and curved guide 520. And, since outrigger is in thesame plane as handle 515 and curved guide 520, the distal tip 523 ofcurved guide and the outrigger extension 553 should be in generally thesame plane as well. As such, the outrigger extension 553 may provide aline of sight for the surgeon to orient himself as to where the pin willexit from the side of the femur and the surrounding skin. The line ofsight allows the surgeon to locate the exiting portion of the pinquickly, and perform any necessary preparation of the surrounding skinprior to the pin passing through the skin and possibly creatingunnecessary damage, such as excessive tearing of the skin, for example.The surgeon may direct the curved guide tool 510 into the joint at anyangle, depending on the orientation of the handle 515 relative to thefemur and tibia. Thus, the line of sight laid out by extension 553 maynot be directly over the midline of the knee and femur but may insteadbe medial or lateral of this midline. Alternatively, it is recognizedthat if the tool 510 includes a movable screw rather than a setscrew526, the surgeon may rotate the curved guide 520 around its axis, andthe distal end 522 will thus curve to one side or the other of theplane, then the outrigger extension 553 and distal end 522 may not be ina single plane and the line of sight may be compromised. To alleviatethis scenario, the outrigger 550 swivel connection 554 may instead bepositioned on the portion 521 or 528 of curved guide such that outrigger550 will remain in the same plane as the curved portion 522 of thecurved guide 520.

Once the pin is passed through the femur and surrounding skin, the guidetool 510 may be removed from the surgical area. Alternativeinstrumentation, such as flexible reamer 30, 130, or the like, may thenbe used to widen the tunnel in the femur, prepare the tibia, and thenthe ACL graft may be placed and secured as is known in the art.

In an alternative embodiment of the above method, curved guide tool 610may be used. The method is similar to the example discussed above withtool 510, except for the step of placement of the curved guide 620 ontothe bone, such as the femur. Guide tool 610 may include flange 629,which is not intended to dig into bone. Rather, and as illustrated inFIGS. 27 and 28, flange 629 includes surface 624 which may be generallyadapted to substantially mate with or index soft tissue or hard tissuenear the surgical site, for example, a portion of a lateral condyle onthe femur in the knee joint. For example, the surface 624 substantiallymimics the surface of a portion of the lateral condyle such that itsubstantially mates with the condyle creating a stable connection whichmay alert the surgeon that the curved guide 620 is in a proper position.More particularly, for example, the flange 629 substantially mates withthe posterior portion of the lateral condyle (FIG. 28). Of course, theshape of the flange 629 would vary depending on its use in a left kneeor a right knee.

In yet a further embodiment, tool 510 and tool 610 may be used inconjunction with one another. For example, tool 510 may be firstpositioned into the joint, and the distal tip 523 used as an awl to markthe correct placement of the pin. For this embodiment, curved guide 520of tool 510 may be solid, such that it is not hollow or cannulated. Tool510 then may be removed from the joint, and tool 610 may then beinserted such that flange 629 positions on the surrounding tissue, e.g.,distal portion of a lateral condyle on the femur, and once in properposition, and presumably aligned with the mark left by tool 510, a pinmay be passed through curved guide 620 and into the femur. In a furtheralternative, only tool 610 would be used and a flexible starter awl maybe passed through curved guide 620 to mark the correct anatomicalposition on the bone. The awl may then be removed and the pin passedinto the curved guide 620 and into the femur.

Once the flange 629 is mated with the particular portion of the condyleits shape may substantially mimic, the distal portion 622 of curvedguide 620 may be in the desired location to perform further steps, suchas the passage of a pin, for eventual attachment of the soft tissue,such as an ACL graft, as discussed in other embodiments.

In yet another embodiment of ACL repair, using tool 810, a surgeonestablishes a flow of clear liquid into the joint to increasevisibility, using a fluid pump or the like (not shown). This step isinherent in any arthroscopic surgical procedure, including any of thosedescribed above. The surgeon next may create an anterior-medial portal(not shown) in the tissue surrounding the knee joint, as is known in theart. A surgeon, for example, using the tool 810, holding the handle 830,may position distal end 828 of the cannulated guide 820 through theanterior-medial portal, and into or adjacent to the joint. The plug 812may be in the closed position during this insertion step, though it maybe in the open position as well to, for example, release any air presentin the cannulated opening. Once the tool 810 is in position, the plugmay remain in the closed position until a time where the surgeon isready to use tool 810.

With cannulated guide 820 in place, a flexible pin, or the like, may bepassed up through the cannula entry and into the cannula guide 820 andpassed into the femur using any known means, such as a power drill,mallet, or the like. Outrigger 850 may also be used to assist in guidingthe pin into a proper position, as is discussed in detail above.

Once the pin is passed into the joint, the dam 814 may be closed again,or the guide tool 810 may be removed from the surgical area altogether.Alternative instrumentation, such as a flexible reamer or the like, maythen be used to perform the surgical procedure.

The various instrumentation of the present invention may be groupedtogether in any any combination. Such instrumentation systems mayinclude, for example, at least one flexible pin, at least one femoralaimer, at least one curved guide tool, and at least one flexible reamer.The system may further include at least one awl, suture, tissue graftpreparation instruments, and any other instrumentation which may be usedin arthroscopic surgical procedures. It should be noted that any of thebelow instrumentation system examples may include such instrumentationas suture, graft preparation instruments, and the like, as may be usedin typical orthopedic arthroscopic surgical procedures.

In yet a further system, at least one of tool 510, tool 610 and tool810, for at least a right or left knee, may be packaged with additionalinstrumentation needed for additional steps of, for example, ACL repair,such as at least one flexible drill pin 10, 110, 210, at least onefemoral aimer 20, 120, 220, 320, 420, at least one femoral reamer 30,130, or any other instrumentation known in the art.

Any other combination of the instrumentation of the present inventionmay also form a system. For example, at least one flexible pin and atleast one flexible reamer may be combined as a system. Such a system mayfurther include at least one femoral aimer, or alternatively, at leastone curved guide tool. Such a system may further include at least onestarter awl or at least one non-cannulated curved guide tool which mayalso operate as a starter awl.

In another combination, one instrumentation system may include at leastone flexible pin and one of either an at least one femoral aimer or anat least one curved guide tool. Such a system may further include aflexible reamer, a starter awl, or the like.

A further exemplary instrumentation system may include a flexible reamerand one of either an at least one femoral aimer or an at least onecurved guide tool. The system may further include a flexible pin, astarter awl, or the like.

Of course, an instrumentation system may also be combinable even whereeach instrument is packaged and arranged separately. For example, aninstrumentation system including a flexible pin, flexible reamer, and atleast one of a femoral aimer and a curved guide tool, may be packagedfor a surgeon separately, meaning each instrument is sold separately andpackaged individually. Alternatively, for example, each individualinstrument may be available separately, and when a surgeon orders theinstrumentation, the specific instrumentation ordered may be groupedtogether and packaged in a tray (not shown), which is then sterilizedand sent to the surgeon. Thus, in this example, it is conceivable thatevery system of the present invention delivered to surgeons may bedifferent from one another such that each system is tailored to fit thespecific needs of the particular surgeon.

As yet another example, in one alternative of an instrumentation kit, itis envisioned that a curved guide tool may be part of a kit in which atool 610 for a left knee and a tool 610 for a right knee are packagedtogether. Alternatively, a tool 610 could be packaged as a kit withdetachable flanges 629, detachable at connection site 625, including atleast one for the right knee and at least one for the left knee, orvarious flanges for a single knee but with various first and secondoffsets, or any combination of such. In yet a further alternative, atleast two of tool 510, tool 610 and tool 810 may be packaged as a kitfor either the left or right knee. Of course, an individual tool, forone of the right knee or left knee, could be packaged individually, oras a system in any combination of those discussed above.

A further kit may include various versions of a femoral aimer 20, 120,220, 320, 420 with which a surgeon can determine which aimer best suitsthe particular characteristics of a surgical procedure. Such a kit maybe specific to a left or a right knee. Alternatively, such a kit mayinclude at least one femoral aimer for both a right and left knee. Ofcourse, an individual aimer, for one of the right knee or left knee,could be packaged individually, or as a system in any combination ofthose discussed above.

These exemplary embodiments of various methods, instrumentation systemsand kits may be used when the knee is positioned at a “normal” flexion,for example, at ninety degrees, and a knee holder (as is known in theart) may also be used, if needed. These methods reduce the need of asurgeon to hyperflex the knee, as well as providing methods of repairingan ACL in a knee that cannot undergo hyperflexion. However, thecurvature of the drill pin 10, 110, 210, the curved guide 510, 610, 810and consequently the reamer 30, 130 may vary such that theinstrumentation, kits and methods of the present invention may be usedon a knee, or other joint, bent at any degree of flexion.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

We claim:
 1. An instrumentation system for preparing a bone for softtissue repair, the instrumentation system comprising: a flexible drillpin capable of bending along a curved path, the flexible drill pinformed of a shape memory material; an aimer capable of engaging theflexible drill pin to bend the flexible drill pin, the aimer having aforked tip at its distal end, the forked tip including spaced apartforks allowing disengagement of the aimer from the flexible drill pin ina first direction transverse to a longitudinal axis of the flexibledrill pin; and a cannulated flexible reamer having a flexible portionalong at least a portion of its length, the flexible portion comprisinga plurality of laser cuts, wherein the flexible portion is cannulatedalong at least a portion of its length for placement over at least thebent portion of the flexible drill pin.
 2. The instrumentation system ofclaim 1, wherein the aimer at least substantially surrounds acircumference of the flexible drill pin.
 3. The instrumentation systemof claim 1, wherein the flexible portion of the flexible reamercomprises discrete, interlocking portions.
 4. The instrumentation systemof claim 1, wherein the flexible reamer comprises an asymmetric tiphaving at least one flute positioned off-axis relative to a longitudinalaxis of the flexible reamer.
 5. The instrumentation system of claim 1,wherein the flexible drill pin is composed of Nitinol.
 6. Theinstrumentation system of claim 1, wherein the flexible drill pinfurther comprises a distal portion and a proximal portion, wherein thedistal portion includes a trocar tip and the proximal portion includes asuture connection.
 7. The instrumentation system of claim 1, wherein thespaced apart forks of the forked tip of the aimer remain fixed inposition relative to each other.
 8. The instrumentation system of claim1, wherein the spaced apart forks of the forked tip of the aimer extendfrom a shaft of the aimer in a second direction transverse to alongitudinal axis of the aimer.
 9. The instrumentation system of claim1, wherein the spaced apart forks of the forked tip of the aimer extendfrom a shaft of the aimer in a second direction parallel to alongitudinal axis of the aimer.
 10. The instrumentation system of claim1, wherein the spaced apart forks of the forked tip of the aimer form anengagement surface for surrounding a circumference of the flexible drillpin when the aimer is engaged with the flexible drill pin, and whereinthe engagement surface is shaped such that the longitudinal axis of theflexible drill pin may define an oblique angle with a longitudinal axisof the shaft of the aimer when the aimer is surrounding thecircumference of the flexible drill pin.
 11. A method for preparing abone tunnel in a femur adjacent a knee joint, comprising: introducing aflexible drill pin into the knee joint, the flexible drill pin formed ofa shape memory material; guiding the flexible drill pin towards asurface of the femur with an instrument introduced into the knee joint,wherein the instrument guides the flexible drill pin along a curved pathtowards the surface of the femur, the instrument having a forked tip atits distal end, the forked tip including spaced apart forks allowingdisengagement of the instrument from the flexible drill pin in a firstdirection transverse to a longitudinal axis of the flexible drill pin;drilling the flexible drill pin into the femur along a substantiallylinear path; removing the instrument from the knee joint; introducing acannulated flexible reamer into the knee joint by placing the flexibledrill pin within the cannulation of the flexible reamer, the flexiblereamer comprising a flexible portion along at least a portion of itslength such that the flexible portion is positioned over at least thecurved path of the flexible drill pin; and reaming the bone tunnel inthe femur along the path of the flexible drill pin.
 12. The method ofclaim 11, wherein the instrument comprises a femoral aimer or a curvedguide tool.
 13. The method of claim 11, wherein the flexible portioncomprises a plurality of laser cuts.
 14. The method of claim 13, whereinthe flexible portion of the flexible reamer comprises discrete,interlocking portions.
 15. The method of claim 11, wherein the flexibledrill pin, instrument, and flexible reamer are introduced into the kneejoint through an at least one portal.
 16. The method of claim 11,wherein the flexible drill pin and flexible reamer are introduced intothe knee joint through a bone tunnel through a tibia, and the instrumentis introduced into the knee joint through a portal.
 17. The method ofclaim 11, wherein the flexible drill pin is drilled through the femurand exits out a lateral side of the femur.
 18. The method of claim 17,wherein the flexible drill pin follows a curved path from introductionin the knee joint to the surface of the femur, and follows a generallystraight and substantially linear path from the surface of the femur,through the femur, and out the lateral side of the femur.
 19. The methodof claim 11, wherein the spaced apart forks of the forked tip of theinstrument remain fixed in position relative to each other.
 20. Themethod of claim 11, wherein the spaced apart forks of the forked tip ofthe instrument extend from a shaft of the instrument in a seconddirection transverse to a longitudinal axis of the instrument.
 21. Themethod of claim 11, wherein the spaced apart forks of the forked tip ofthe instrument extend from a shaft of the instrument in a seconddirection parallel to a longitudinal axis of the instrument.
 22. Themethod of claim 11, wherein the spaced apart forks of the forked tip ofthe instrument form an engagement surface for surrounding acircumference of the flexible drill pin when the instrument is engagedwith the flexible drill pin, and wherein the engagement surface isshaped such that the longitudinal axis of the flexible drill pin maydefine an oblique angle with a longitudinal axis of the shaft of theinstrument when the aimer is surrounding the circumference of theflexible drill pin.